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Copyright 2005 by AMERICAN UROLOGICAL ASSOCIATION DOI: 10.1097/01.ju.0000156556.11235.3f
HIGHLY POTENT AND MODERATELY POTENT TOPICAL STEROIDS ARE EFFECTIVE IN TREATING PHIMOSIS: A PROSPECTIVE STEPHEN SHEI DEI YANG, YAO CHOU TSAI, CHIA CHANG WU, SHIH PING LIU From the Department of Urology, En Chu Kong Hospital, Taipei Medical University and Department of Urology, College of Medicine (SPL), National Taiwan University, Taipei, Taiwan Purpose: We report a prospective randomized study comparing the effects of highly potent and moderately potent topical steroids in treating pediatric phimosis.
Materials and Methods: A total of 70 boys 1 to 12 years old with phimosis were randomly assigned to receive topical application of either betamethasone valerate 0.06% (a highly potentsteroid) or clobetasone butyrate 0.05% (a moderately potent steroid). Parents of the boys wereinstructed to retract the foreskin gently without causing pain, and to apply the topical steroidsover the stenotic opening of the prepuce twice daily for 4 weeks, then for another 4 weeks if noimprovement was achieved. Retractibility of the prepuce was graded from 0 to 5. Response totreatment was arbitrarily defined as improvement in the retractibility score of more than 2points.
Results: Mean treatment and followup periods were 4.3 and 19.1 weeks, respectively. The response rates in boys treated with betamethasone valerate and clobetasone butyrate were 81.3%and 77.4%, respectively (p ϭ 0.63). Mean retractibility score decreased from 3.9 Ϯ 1.0 to 1.7 Ϯ 1.1,and 4.2 Ϯ 1.0 to 1.9 Ϯ 1.0 in the betamethasone and clobetasone groups, respectively. Bothsteroids were effective in all age groups. Pretreatment retractibility score did not affect treatmentoutcomes. No adverse effect was encountered.
Conclusions: Highly potent and moderately potent topical steroids are of comparable effective- ness in treating phimosis. A less potent steroid may be considered first to decrease the risk of thepotential adverse effects.
KEY WORDS: steroids, phimosis, penis, circumcision Because of medical, religious or social reasons, circumci- sion has long been advocated as an effective way to treat A total of 70 boys 1 to 12 years old (mean age 4.7 Ϯ 2.6 phimosis. Circumcision may result in complications such as years) with phimosis were enrolled in this study between meatal stenosis, meatitis, meatal ulceration, postoperative 2001 and 2003. The Appendix shows the grades of retract- infection, anesthesia related adverse events and psychologi- ibility of phimosis from 0 to 5 suggested by Kikiros et al.2 The cal trauma.1 To avoid the hazards of circumcision, topical associated presenting symptoms were penile pain and/or corticosteroids have been used as an alternative for phimosis, itching in 33 patients, preputial ballooning during voiding in and high success rates (67% to 95%) have been reported.2-9 9, voiding pain in 6, slow urinary stream in 6, urinary fre- The relative strengths of topical steroids are divided into quency in 4 and concern over apparent phimosis in 12. Uri- ultrahigh, high, moderate and low potency categories accord-ing to the recommendations of the British National Formu- nalysis and urine culture were performed in patients who lary.10 Inhibition of the pituitary-adrenal axis by excessive complained of penile pain or voiding pain. Before application application of stronger steroids has been well documented.11 of topical steroids boys with balanitis and urinary tract in- Growth stunting in a child treated with long-term fluori- fection were adequately treated with antibiotics. Boys with nated steroids has been observed but the weaker steroids are phimosis secondary to incomplete circumcision were ex- considered safe in children.12, 13 Thus, to decrease the possi- ble adverse effects, it is sensible to prescribe the weakest Patients were randomly assigned to receive topical appli- effective topical steroid possible in pediatric practice. How- cation of either betamethasone valerate 0.06% (a highly po- ever, to date, all but 2 reports on topical steroids for pediatric tent steroid) or clobetasone butyrate 0.05% (a moderately phimosis used ultrahigh or high potency steroids.2, 7 These 2 potent steroid). Parents of the boys were instructed to retract studies using less potent steroids were neither prospective the foreskin gently without causing pain, and to apply the nor randomized controlled trials. Therefore, we conducted a topical steroids over the stenotic opening of the prepuce and prospective randomized study to compare the effects of topi- the adhesion between the prepuce and glans twice daily for 4 cal application of highly potent and moderately potent ste- weeks, then for another 4 weeks if no improvement was achieved. The principal investigator (SSDY), who wasblinded to the treatment arm, evaluated the treatment out- Submitted for publication April 19, 2004.
comes and adverse effects at 2, 4 and 8 weeks after treat- * Correspondence: Department of Urology, En Chu Kong Hospital, ment. A clinical research nurse, also blinded to the treatment 399 Fushing Rd., Taipei Hsien 237, Taiwan (telephone: 886-2- arm, telephoned the parents of patients with a structured 26723456, ext. 6351; FAX: 886-2-26719512; e-mail: ericwcc@ms27.hinet.net).
questionnaire covering the grades of retractibility, improve- HIGHLY POTENT AND MODERATELY POTENT STEROIDS FOR PHIMOSIS ment in associated presenting symptoms and possible side Chu4 et al have independently reported prospective studies effects at 12 and 24 weeks after treatment.
demonstrating that the efficacy of steroid application was Response to topical steroid application was arbitrarily de- superior to that of gentle retraction or application of neutral fined as improvement in the retractibility score of more than cream only. The main purposes of this study were to inves- 2 points as suggested by Atilla et al.14 The results in boys tigate whether weaker potency steroids are similarly effec- older than 3 years were compared to those in boys 3 years or tive in boys with phimosis, and to determine the influence of younger. The Wilcoxon signed rank, Student t and chi-square tests were used for statistical analysis.
Using steroid cream to treat phimosis was sensible and prac- tical. Three possible mechanisms of action of topical steroids have been proposed in the treatment of phimosis. Steroids can Seven boys (3 in the betamethasone group and 4 in the cause thinning of skin and improve the elasticity of the foreskin clobetasone group) were lost to followup, leaving 63 eligible by decreasing synthesis of hyaluronic acid, which has an anti- for investigation. Mean treatment duration was 4.3 weeks proliferative effect on the epidermis.15 In addition, topical steroids can inhibit the production of the mediators of skin The table compares the demographic data and therapeutic inflammation, prostaglandins and leukotrienes.16 Finally, results. There were no statistical differences in age (mean the lubricant effect of the cream allows boys to retract the age 4.9 Ϯ 2.5 and 4.5 Ϯ 2.9 years, respectively, p ϭ 0.31) or pretreatment retractibility score (mean score 3.9 Ϯ 1.0 and Elmore et al9 and we have proved the therapeutic effects of 4.2 Ϯ 1.0, respectively, p ϭ 0.32) between the 2 groups. The topical steroids for phimosis in children younger than 3 retractibility score improved to 1.7 Ϯ 1.1 and 1.9 Ϯ 1.0 in years. Adherence of the prepuce to the glans in infants and the betamethasone and clobetasone groups, respectively young boys is considered physiological, and expectant treat- (p Ͻ0.01 in each group). The response rates were similar ment has been suggested because of spontaneous resolution between the 2 groups (81.3% vs 77.4%, p ϭ 0.63). Excellent with age. But boys with physiological phimosis are often results of grade 0 or 1 were achieved in 16 (50%) and 14 referred to urologists for surgery. Topical steroid therapy can (45.2%) boys in the betamethasone and clobetasone groups, offer a potential alternative to avoid unnecessary circumci- respectively. Patient age did not affect treatment outcomes sion. In addition, although treatment is usually recom- significantly in each group. No significant differences were mended after age 3 years, early treatment will be beneficial found in the pretreatment retractibility score in the respond- to boys younger than 3 years with signs of ballooning with ers and nonresponders (4.0 Ϯ 0.9 vs 3.8 Ϯ 1.2 in the beta- voiding, urinary tract infection and balanitis,5, 9 as circumci- methasone group, p ϭ 0.42, and 4.3 Ϯ 0.9 vs 4.1 Ϯ 1.0 in the sion has been proved to be effective in preventing recurrent urinary tract infection in patients younger than 6 months, After treatment circumcision was recommended in boys who have a high incidence of periurethral bacterial coloniza- with grade 4 or 5 phimosis. Two thirds of patients in the betamethasone group and half of those in the clobetasone There are no universally accepted criteria defining "suc- group underwent circumcision because of remaining high cessful therapy" for phimosis. To compare the effects of ste- roids, we adopted the "2-point difference" after treatment as No significant adverse effect was encountered during the suggested by Atilla et al.14 In daily practice adequate care study period. Therapeutic effects were maintained in all but and cleaning of the foreskin and glans are the concerns of 1 patient who responded to the application of topical steroids.
genital hygiene. Even in cases of complete phimosis a 2-point The 1 reported recurrence of phimosis was successfully difference will result in a grade of 3 or less. Thus, the prepuce treated with topical clobetasone butyrate. During followup no can be pulled back easily to expose the glans and urethral recurrent infection or associated presenting symptoms were meatus. As shown in this study, circumcision can be avoid- detected in boys with a history of balanitis and urinary tract able in most cases because of decreasing infection rate and Compliance with medication, rather than age or pretreat- ment grades of phimosis, may be the key factor predicting We report the first known prospective randomized con- successful treatment outcome. In the current study mean trolled study to compare different potency steroids in treat- pretreatment score of phimosis was comparable in the re- ing phimosis. The study reveals that highly potent and mod- sponders and nonresponders in the 2 groups. Orsola et al erately potent topical steroids are equally effective. The reported that a highly potent topical steroid for phimosis was achieved response rates (81.3% for highly potent and 77.4% effective in boys older than and younger than 5 years.6 How- for moderately potent steroids) are comparable to the success ever, Monsour et al found that older boys applied the cream rates (67% to 95%) reported in previous studies. Almost all rather than their parents, so patients in whom treatment studies used ultrahigh or high potency steroids, and the 2 failed were older than those with a successful outcome (mean studies using less potent steroids were retrospective.2-9 Al- age 10.6 versus 6.3 years).5 We agree with the conclusion of though this study was not placebo controlled, Golubovic3 and Wright that parent and patient compliance was the key fac- Demographic data and therapeutic results in boys with phimosis treated with highly potent and moderately potent topical steroids HIGHLY POTENT AND MODERATELY POTENT STEROIDS FOR PHIMOSIS tor in predicting successful treatment.19 In our series mean 2. Kikiros, C. S., Beasley, S. W. and Woodward, A. A.: The response patient age was only 4.7 years. Good compliance (90%) was of phimosis to local steroid application. Pediatr Surg Int, 8:
noted, because most topical steroid was applied by the par- ents. As a result, our study revealed that patient age did not 3. Golubovic, Z., Milanovic, D., Vukadinovic, V., Rakic, I. and Perovic, S.: The conservative treatment of phimosis in boys.
No significant adverse effects were encountered from the Br J Urol, 78: 786, 1996
4. Chu, C.-C., Chen, K.-C. and Diau, G.-Y.: Topical steroid treat- use of the 2 topical steroids in this and previous studies of ment of phimosis in boys. J Urol, 162: 861, 1999
phimosis.2-9 Morning cortisol levels of boys treated with be- 5. Monsour, M. A., Rabinovitch, H. H. and Dean, G. E.: Medical tamethasone did not differ from controls.3 However, when management of phimosis in children: our experience with top- therapeutic trends change from surgical circumcision to local ical steroids. J Urol, 162: 1162, 1999
medical application more and more steroids will be used by 6. Orsola, A., Caffaratti, J. and Garat, J. M.: Conservative treat- physicians. Infants and young children have delicate, easily ment of phimosis in children using a topical steroid. Urology, damaged skin and a high surface area-to-body volume, mak- 56: 307, 2000
ing them susceptible to systemic absorption of topical ste- 7. Ng, W. T., Fan, N., Wong, C. K., Leung, S. L., Yuen, K. S., Sze, roids. Using stronger topical steroids may carry a higher risk Y. S. et al: Treatment of childhood phimosis with a moderately of adverse effects, including iatrogenic Cushing syndrome, potent topical steroid. ANZ J Surg, 71: 541, 2001
adrenal suppression, delayed growth and skin atrophy, 8. Ashfield, J. E., Nickel, K. R., Siemens, D. R., MacNeily, A. E. and Nickel, J. C.: Treatment of phimosis with topical steroids in which have been observed in children treated with topical or 194 children. J Urol, 169: 1106, 2003
intranasal steroids.11-13, 20 Thus, it is practical to use moder- 9. Elmore, J. M., Baker, L. A. and Snodgrass, W. T.: Topical steroid ately potent steroids first, since they are suggested by our therapy as an alternative to circumcision for phimosis younger study to be as effective as highly potent steroids. Further than 3 years. J Urol, 168: 1746, 2002
investigation is still needed to determine whether mildly 10. MacKie, R. M.: Drug eruptions. In: Clinical Dermatology, 5th ed.
potent (the weakest potency) topical steroids are also effec- New York: Oxford University Press, p. 300, 2004 11. Cornell, R. C. and Stoughton, R. B.: Six-month controlled study of effect of desoximetasone and betamethasone-17-valerate on
the pituitary-adrenal axis. Br J Dermatol, 105: 91, 1981
12. Borzykowski, M., Grant, D. B. and Wells, R. S.: Cushing's syn- Highly potent and moderately potent topical steroids are drome induced by topical steroids used for the treatment of effective and of comparable therapeutic efficacy in treating non-bullous ichthyosiform erythroderma. Clin Exp Dermatol, phimosis. Patient age and pretreatment retractibility score 1: 337, 1976
are not prognostic factors regarding the outcome of topical 13. Krafchik, B. R.: The use of topical steroids in children. Semin steroid treatment. When topical steroid application is at- Dermatol, 14: 70, 1995
tempted to treat phimosis moderately potent steroids should be considered first to avoid potential adverse effects, even the Go¨kc¸ay, E.: A nonsurgical approach to the treatment of phi-mosis: local nonsteroidal anti-inflammatory ointment applica- tion. J Urol, 158: 196, 1997
15. Zheng, P. S., Lavker, R. M., Lehmann, P. and Kligman, A. M.: Morphologic investigations on the rebound phenomenon aftercorticosteroid-induced atrophy in human skin. J Invest Der- matol, 82: 345, 1984
Grade 1-full retraction of prepuce and tight ring behind 16. Kragballe, K.: Topical corticosteroids: mechanisms of action.
Acta Derm Venereol Suppl, 151: 7, 1989
17. Wiswell, T. E., Miller, G. M., Gelston, H. M., Jr., Jones, S. K. and Grade 3-partial retraction with urethral meatus just visi- Clemmings, A. F.: Effect of circumcision status on periurethral bacterial flora during the first year of life. J Pediatr, 113: 442,
Grade 4-slight retraction but urethral meatus and glans 18. To, T., Agha, M., Dick, P. T. and Feldman, W.: Cohort study on circumcision of newborn boys and subsequent risk of urinary-
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1. Cuckow, P. M.: Circumcision. In: Pediatric Surgery and Urology: 20. Perry, R. J., Findlay, C. A. and Donaldson, M. D.: Cushing's Long Term Outcomes. Edited by M. D. Stringer, K. T. Oldham, syndrome, growth impairment, and occult adrenal suppres- P. D. E. Mouriquand and E. R. Howard. London: W. B. Saunders sion associated with intranasal steroids. Arch Dis Child, 87:

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